A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects

Abstract

Objectives: The primary aim of this study was to assess the change in acne lesions and severity within all treatment groups over the course of a six-month study.

Methods: This was a six-month, multisite, randomized, double-blind, controlled study in female subjects with mild-to-moderate acne to assess the clinical and psychological outcomes of treatment with biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, 2.5% benzoyl peroxide (BPO) gel, and placebo. Subjects applied the assigned product to their face twice daily and were evaluated for clinical acne and quality of life outcomes at baseline and after six, 12, 18, and 24 weeks of treatment.

Results: After 24 weeks of use, subjects treated with biofilm disrupting acne cream 2x had a significantly greater improvement in the Investigator Global Assessment (IGA), compared to those treated with 2.5% BPO gel. Based on dermatologic assessments, biofilm disrupting acne cream 2x, biofilm disrupting acne cream 1x, biofilm disrupting acne cream without salicylic acid, and placebo control were associated with less erythema and dryness, compared to 2.5% BPO gel.

Limitations: Assessments within this study had the potential for subjective differences due to variability between evaluators.

Conclucion: Biofilm disrupting acne cream 2x and biofilm disrupting acne cream 1x provided equivalent efficacy to 2.5% BPO gel with less of the adverse effects commonly associated with BPO, such as erythema and dryness. Both the biofilm disrupting acne cream without salicylic acid and the placebo control were associated with mild improvements to acne symptoms over the course of the 24-week study.

Trial registry information: ClinicalTrials.gov, NCT03106766.

Keywords: Acne vulgaris; Cutibacterium acnes; Investigator’s Global Assessment; biofilm; lesions; quality of life; sebaceous gland disease; skin disease.

FIGURE 1.

Investigator Global Assessment. A: Next Science acne cream 2x; B: Next Science acne cream 1x; C: Next Science without salicylic acid; D: 2.5% benzoyl peroxide gel; E: placebo control. Grade 0: clear skin with no inflammatory or noninflammatory lesions. Grade 1: almost clear; rare noninflammatory lesions present with rare noninflamed papules. Grade 2: mild; some noninflammatory lesions with few inflammatory lesions (papules/pustules only, no nodules). Grade 3: moderate; noninflammatory lesions predominate, with multiple inflammatory lesions evident; several to many comedones and papules/pustules are present, and there may or may not be one small nodulocystic lesion. Grade 4: severe; inflammatory lesions more apparent; many comedones and papules/pustules, and there may or may not be a few nodulocystic lesions. Grade 5: highly inflammatory lesions predominate; variable number.

FIGURE 2.

Clinical assessments: differences from baseline treatment. A: Next Science acne cream 2x; B: Next Science acne cream 1x; C: Next Science without salicylic acid; D: 2.5% benzoyl peroxide gel; E: placebo control.

FIGURE 3.

Dermatological assessments: differences from baseline. A: Next Science acne cream 2x; B: Next Science acne cream 1x; C: Next Science without salicylic acid; D: 2.5% benzoyl peroxide gel; E: placebo control.

FIGURE 4.

Subjective assessments: differences from baseline. A: Next Science acne cream 2x; B: Next Science acne cream 1x; C: Next Science without salicylic acid; D: 2.5% benzoyl peroxide gel; E: placebo control.